Hulscher notes that "the proper conditions for market withdrawal have been met" and he lists the main points:

Regulatory Classification and Guidelines:

• COVID-19 modRNA vaccines were misclassified as traditional vaccines rather than gene therapy products, bypassing stricter regulatory requirements.

• WHO guidelines from 2005 were used for nonclinical assessments, despite being outdated and inapplicable to modRNA vaccines.

Spike Protein and Safety Concerns:

• The spike protein produced by modRNA vaccines is toxic and can cause immune-related complications.

• Studies on pharmacokinetics (how much spike protein is produced, where it distributes, and how long it persists) were not conducted as part of Pfizer's submission.

• Spike protein production varies among individuals based on genetics, health status, and other factors, but this variability was never studied.

Biodistribution and LNP Behavior:

• Pfizer's own biodistribution data showed lipid nanoparticles (LNPs) and modRNA were widely distributed throughout the body, including the liver, spleen, ovaries, and adrenal glands.

• Contrary to claims, spike protein production was not limited to the injection site, raising concerns about off-target effects and toxicity.

Toxicology and Carcinogenicity Testing:

• Pfizer did not conduct genotoxicity or carcinogenicity studies, despite the potential for the spike protein and LNPs to cause harm.

• Wistar Han rats, which are not a relevant species for SARS-CoV-2 toxicity studies, were used inappropriately in preclinical testing.

Deficient Clinical Trials:

• Phase I clinical trials failed to measure critical factors like the amount and variability of spike protein produced in individuals.

• Placebo groups in initial trials were unblinded early, undermining the integrity of long-term safety and efficacy data.

Adverse Events and VAERS Reporting:

• Post-authorization data from Pfizer showed 1,223 deaths and numerous serious adverse events within the first three months of vaccine rollout.

• The Vaccine Adverse Event Reporting System (VAERS) documented a huge spike in reported adverse events following the COVID-19 vaccine rollout, far exceeding reports for previous vaccines.

• Despite the massive increase in reported deaths and injuries, no corrective actions were taken. This contrasts with earlier vaccines like Rotashield , which were removed after only 15 cases of intussusception.

  1. Regulatory Oversight Failures:

     • The FDA and other global regulatory agencies overlooked or dismissed major concerns raised during the review process.

     • Regulatory assessments relied on insufficient data and assumptions rather than rigorous scientific evidence.

  2. Call for a Moratorium:

     • Based on incomplete data, serious safety concerns, and potential long-term risks, the authors recommend a moratorium on Pfizer/BioNTech's COVID-19 modRNA vaccines.

     • Proper studies must be conducted to ensure safety, as the responsibility lies with the pharmaceutical industry, not independent scientists.